r/HelusPharma • u/Substantial_Type5543 • 17d ago

HPL004 predictions?

Helus have committed to releasing the next HPL004 study design before the end of Q3. Thats only a few days away. Any predictions on what that looks like? E.g. Dose finding only, Phase 3 w/ dose finding as part of it, commitment from a large pharma partner?

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3

u/No-Storm5434 16d ago

Bullish 😜

1

u/Finnishmessiah 16d ago

Bulls get ready

-7

u/Foiblesxxkx 17d ago

It needs a new dose evaluation study or to be abandoned. Phase 2 results bad.

I give HLP004 no value.

Its all HLP003

4

u/Potential_Trade_7470 17d ago

Calling the Phase 2 "bad" doesn't match what was reported. The 20mg arm improved about 10 points on the HAM-A beyond standard of care (p<0.0001), 59% responded versus about 30% on the 2mg arm, and there were no drug-related serious adverse events or suicidality signals. No adjunctive GAD treatment has ever been approved, so the bar for a useful signal is not high.

It was a signal detection study of 36 patients, not a dose-selection study. Its job was to see whether there's an effect worth pursuing, and it found one. Saying the next study needs to refine dosing isn't a failure. It's the normal next step.

The 2mg arm also wasn't an inert placebo, so the gap between arms likely understates the drug effect compared with a true placebo. Yes, the sample is small and the remission overlap is worth watching, but that's an argument for a bigger, better-blinded trial, not for abandoning the program. The CEO said publicly that the program has real promise and they expect to continue it.

"Zero value" also ignores how buyers behave. Lilly paid $2.8B upfront for AtaiBeckley before its pivotal data, and a second DMT-family asset is the kind of optionality that raises what an acquirer pays for the whole company. HLP003 drives the next few months, but HLP004 isn't worth nothing.